The goal of this clinical trial is to investigate the effect of continuous versus intermittent enteral nutrition on metabolic outcomes in critically ill adult patients. The aim of this study is to: • To assess the effect of a daytime intermittent tube feeding pattern compared to standard continuous tube feeding on glycaemic control, gastrointestinal function, gastrointestinal hormones, markers of sleep quality and circadian rhythm, and lean body mass and body composition. Participants will receive either continuous enteral nutrition for 24 hours a day or intermittent enteral nutrition during the day, consisting of 4 portions each administered over 1 hour between 8 am and 8 pm. The maximum duration of the intervention is 5 days or until participants do not receive exclusive gastric enteral nutrition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Participants will receive intermittent enteral nutrition in four separate portions between 8:00 a.m. and 8:00 p.m. Each portion will be administered over a one-hour period.
Gelderse Vallei Hospital
Ede, Gelderland, Netherlands
RECRUITINGMartini Ziekenhuis
Groningen, Provincie Groningen, Netherlands
RECRUITINGGlycaemic variability
The primary outcome is the mean glycaemic variability per 24 hours during the intervention, measured with Continuous Glucose Monitoring (CGM), expressed as the Coefficient of Variation (COV). The COV is calculated by dividing the standard deviation by the mean blood glucose level and multiplying by 100. It gives a relative measure of variability, which is helpful in comparing variability between individuals or groups with different mean glucose levels.
Time frame: From enrollment to the end of the intervention at a maximum of 5 days.
Glycaemic control
Assessed by mean and standard deviation of interstitial glucose concentrations and Mean Amplitude of Glycaemic Excursions (MAGE) (mmol/L)
Time frame: From enrollment to the end of the intervention at a maximum of 5 days
Insulin administred during intervention period
Insulin administred during intervention period (IU/day)
Time frame: From enrollment to the end of the intervention at a maximum of 5 days
Dysglycemic events during intervention period
Number of hypoglycaemic events, defined as blood glucose level \<4.0 mmol/L and number of hyperglycaemic events, defined as blood glucose level \>10.0 mmol/L
Time frame: From enrollment to the end of the intervention at a maximum of 5 days
Gastrointestinal tolerance during the intervention period
Gastric residual volumes (mL), minimum, maximum and total volume per 24 hours.
Time frame: From enrollment to the end of the intervention at a maximum of 5 days.
Gastrointestinal tolerance during the intervention period
Incidence of vomiting, diarrhoea, constipation and regurgitation during the intervetion periode
Time frame: From enrollment to the end of the intervention at a maximum of 5 days
Circadian rhythm
Assessed by 24-hour curves of melatonin ( pg/mL) in saliva.
Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Circadian rhythm
Assessed by 24-hour curves of cortisol( nmol/L) in saliva.
Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Circadian rhythm
Assessed by 24-hour curves of mRNA expression of essential clock genes (BMAL, CLOCK, Cry1 and Per2).
Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Body composition
Fat-free mass, fat mass and skeletal muscle mass (kg and %) by bio-electrical impendence analysis. This outcome is only measured in centres with the necessary equipment.
Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Muscle size
Cross-sectional area and muscle layer thickness of quadriceps muscle by ultrasonography. This outcome is only measured in centres with the necessary equipment.
Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Nutritional intake during intervention period
Total nutritional prescription and delivery per calendar day (energy in kJ/day, protein in g/day, fat in g/day and carbohydrate in g/day and % of total intake)
Time frame: From enrollment to the end of the intervention at a maximum of 5 days.
Non-nutritonal calories administred during intervention period
Non-nutritional calories delivered by propofol, glucose infusion, and citrate, delivery in kJ per calendar day
Time frame: From enrollment to the end of the intervention at a maximum of 5 days
Health-related quality of life
Health-related quality of life measured with the 36-Item Short Form Health Survey (SF-36), 60 days after ICU admission
Time frame: 60 days after ICU admission
Sleep quality
Sleep quality measured with the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 60 days after ICU admission
Glucoregulatory gastrointestinal hormones
GLP-1, C-peptide, insulin, and glucagon concentrations (mmol/L). This outcome is only measured in the coordinating centre.
Time frame: From 12:00 until 14:00 on the second study day.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.